GSK announced that it has filed regulatory submissions in the USA and Europe for mepolizumab for approval as a maintenance treatment for patients with severe eosinophilic asthma, identified by a blood eosinophil count of at least 150 cells per microlitre at the start of treatment or 300 cells per microlitre in the past 12 months. The submissions comprise:

A Biologics License Application to the US Food and Drug Administration as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbation.

A Marketing Authorization Application to the European Medicines Agency as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids.

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

Applicant information

Product/Manufacturing information

Pre-clinical studies

Clinical studies

Labeling

Mepolizumab is a monoclonal antibody that is delivered in a 100mg dose via subcutaneous injection every four weeks. The regulatory submissions in the USA and Europe are based on studies of patients with severe asthma and include the phase III MENSA1 and SIRIUS2 studies published in the New England Journal of Medicine in September 2014 as well as the earlier phase IIb/III DREAM3 study published in the Lancet in 2012. Both the MENSA and SIRIUS studies evaluated patients with blood eosinophils of either 150 or more cells per microlitre at initiation of treatment or 300 or more cells per microlitre in the previous 12 months.